Diisodecyl sebacate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study similar to guideline performed on read-across substance, with limited reporting

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

only four animals in test group (a minimum of 10 animals is recommended); no further details to judge compliance with guideline

GLP compliance:

no

Remarks:

predates GLP

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study was conducted prior to the introduction of the LLNA method legislation.

Test material

Test material information

Constituent 1

Reference substance name:

Diisodecyl adipate

EC Number:

248-299-9

EC Name:

Diisodecyl adipate

Cas Number:

27178-16-1

Molecular formula:

C26H50O4

IUPAC Name:

bis(8-methylnonyl) adipate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): di-isodecyl adipate
- Molecular formula (if other than submission substance): C26H50O4
- Molecular weight (if other than submission substance): 426.677
- Smiles notation (if other than submission substance): C(CCCCC(OCCCCCCCC(C)C)=O)(OCCCCCCCC(C)C)=O
- InChl (if other than submission substance): InChI=1S/C26H50O4/c1-23(2)17-11-7-5-9-15-21-29-25(27)19-13-14-20-26(28)30-22-16-10-6-8-12-18-24(3)4/h23-24H,5-22H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: no data
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: epicutaneous (no details on level of occlusion)

Vehicle:

water

Induction 2

Concentration / amount:

Induction: 100%
Challenge: 1%, 10% or 100%

Challenge

Challenge 1

Route:

other: epicutaneous (no details on level of occlusion)

Vehicle:

water

Challenge 2

Concentration / amount:

Induction: 100%
Challenge: 1%, 10% or 100%

No. of animals per dose:

Four animals treated at induction (sex unspecified). No details on the number of these which were given the 1%, 10% or 100% challenge treatment [but probably all four given all three challenge applications].

Details on study design:

RANGE FINDING TESTS: no data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: "three days" - presumably three treatments
- Exposure period: no data [possibly 24 hours]
- Test groups: four guinea pigs given undiluted DIDA
- Control group: no data
- Site: ears
- Frequency of applications: no data
- Duration: three days of treatment, then challenge four days later
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: no data
- Exposure period: no data
- Test groups: guinea pigs given 1%, 10% or 100%, but no data on numbers
- Control group: no data
- Site: clipped flank
- Concentrations: 1%, 10% or 100%
- Evaluation (hr after challenge): no data

OTHER:

Challenge controls:

No data

Positive control substance(s):

not specified

Results and discussion

Positive control results:

No data

In vivo (non-LLNA)

Results

Reading:

other: challenge reading

Group:

test chemical

Dose level:

challenge with 1%, 10% or 100% DIDA

No. with + reactions:

0

Total no. in group:

4

Clinical observations:

no data

Remarks on result:

other: Reading: other: challenge reading. Group: test group. Dose level: challenge with 1%, 10% or 100% DIDA. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no data.

Any other information on results incl. tables

No erythema was seen - no data is given on whether other parameters (e.g. oedema) were checked, but presumably these would have been reported, if observed.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

DIDA was not sensitising to the skin of four guinea pigs in a pre-GLP study, similar to that described by OECD Guideline 406 (with limitations).

Executive summary:

In a pre-GLP study, similar to that described by OECD Guideline 406, the potential for diisodecyl adipate (a structurally-similar read-across candidate for diisodecyl sebacate) to sensitise the skin of guinea pigs was investigated.

 

Four albino guinea pigs were given topical applications of undiluted DIDA to the ear for three days, then challenged with 1%, 10% or 100% DIDA four days later. No erythema was seen, and diisodecyl adipate was not considered to be a strong sensitiser on this basis.

 

In this study, DIDA showed limited evidence for a lack of skin sensitising potential.